Phase 1/2 Study of BDTX-1535 in Patients with Glioblastoma or Non-Small Cell Lung Cancer with EGFR Mutations

Sponsor: Black Diamond Therapeutics, Inc.

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05256290

Patient View

The BDTX-1535-101 trial assesses BDTX-1535, a 4th generation EGFR inhibitor, in adults with advanced NSCLC or glioblastoma. Phase 1 is complete; Phase 2 is enrolling. Participants self-administer the drug orally in 21-day cycles. Eligibility includes EGFR mutations in NSCLC or EGFR alterations in glioblastoma. The study evaluates safety, PK, CNS, and antitumor activity.

Patient Parameters

Program Overview

BDTX-1535-101 is an open-label, Phase 1 dose escalation and Phase 2 multiple cohort study designed to evaluate the safety, pharmacokinetics (PK), optimal dosage, central nervous system (CNS) activity, and antitumor activity of BDTX-1535. The study population comprises adults with either advanced/metastatic non-small cell lung cancer (NSCLC) with non-classical or acquired epidermal growth factor receptor (EGFR) resistance (EGFR C797S) mutations with or without CNS disease (in Phase 1 and Phase 2), or glioblastoma (GBM) expressing EGFR alterations (Phase 1 only). All patients will self-administer BDTX-1535 monotherapy by mouth in 21-day cycles.

Phase 1 enrollment is now complete. Phase 2 is currently enrolling.

Eligibility Criteria

Exclusion Criteria

  • Known resistant mutations in tumor tissue or by liquid biopsy (eg, T790M, MET).
  • Received more than 1 EGFR TKI therapy (ie, erlotinib or gefitinib) for the treatment of metastatic or recurrent EGFR NSCLC.
  • Any history of interstitial lung disease related to EGFR TKI use.
  • Symptomatic or radiographic leptomeningeal disease.
  • Symptomatic brain metastases or spinal cord compression requiring urgent clinical intervention.
  • Unresolved toxicity from prior therapy.
  • Significant cardiovascular disease.
  • Major surgery within 4 weeks of study entry or planned during study.
  • Ongoing or recent anticancer therapy or radiation therapy.
  • Evidence of malignancy (other than study-specific malignancies) requiring active therapy within the next 2 years.
  • Active hepatitis B or C infection and/or known human immunodeficiency virus (HIV) carrier.
  • Poorly controlled gastrointestinal disorders.

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